MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE ROTHENBERG BOWEL GRASPER INSERT

Model Number	31310C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Damage is most likely due to stress overload.
Event or Problem Description
Allegedly, the jaw of the bowel grasper insert broke off during a laparoscopic lysis of adhesions procedure.The broken jaw was not retrieved and is retained in the patient.

• Brand Name: CLICKLINE ROTHENBERG BOWEL GRASPER INSERT
• Common Device Name: BOWEL GRASPER INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8234084
• Report Number: 9610617-2019-00001
• Device Sequence Number: 16580887
• Product Code: GCJ
• UDI-Device Identifier: 04048551333723
• UDI-Public: 4048551333723
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 31310C
• Device Catalogue Number: 31310C
• Device Lot Number: TU01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other